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NCT03056001 · ClinicalTrials.gov registry record · Phase 2

Safety, Tolerability, and Efficacy of Doxorubicin and Pembrolizumab for Sarcoma

A Phase 2 study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT03056001: Completed Phase 2 study, sponsored by Wake Forest University Health Sciences.

NCT03056001 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03056001, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of doxorubicin in combination with pembrolizumab in subjects with metastatic or unresectable soft tissue sarcoma. Based on previous studies, pembrolizumab may be an effective study treatment.

Primary Outcome

Severe or life-threatening adverse events will be determined for each subject as a binary variable indicating whether or not the subject experienced at least one adverse event that meets the following criteria: is considered a serious adverse event (per CFR 21 Part 312), is study treatment related per the Sponsor-Investigator, and considered to be clinically significant by the Sponsor-Investigator. An adverse event will be considered study treatment related if it is determined that the event is

Interventions

  • DRUG Pembrolizumab
  • DRUG Doxorubicin

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2017-05-01
Est. Completion 2022-11-15
Phase Phase 2
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT03056001 record still lists

NCT03056001 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT03056001 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03056001 about?

NCT03056001 is a clinical study titled "Safety, Tolerability, and Efficacy of Doxorubicin and Pembrolizumab for Sarcoma". The purpose of this study is to evaluate the safety, tolerability and efficacy of doxorubicin in combination with pembrolizumab in subjects with metastatic or unresectable soft tissue sarcoma. Based on previous studies, pembrolizumab may be an effective study treatment.

What is the current status of trial NCT03056001?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2017-05-01. Estimated completion is 2022-11-15.

What interventions are being tested in trial NCT03056001?

The interventions under investigation include: Pembrolizumab (DRUG), Doxorubicin (DRUG).

Who is sponsoring clinical trial NCT03056001?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03056001's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03056001, the US trial registry maintained by the National Library of Medicine. NCT03056001 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.